EU4Health projects supporting the development of orphan medical devices for children with rare diseases

Orphan medical devices are designed to diagnose or treat rare diseases or conditions that affect a small number of patients. Because of their very specific use and target, they are often difficult to develop, with challenges in access to the market and in addressing unmet medical needs.  

Under the EU4Health programme, three projects support the development of orphan medical devices for paediatric patients, with the goal of providing appropriate care for children living with rare diseases. 

OrphaDev4Kids 

OrphaDev4Kids is helping advance the development and availability of orphan medical devices through a dedicated platform that connects researchers, companies and developers with specialised services, expertise and infrastructure. These services include technical and regulatory guidance, networking opportunities and support in identifying funding opportunities. The project is currently supporting the development of five innovative orphan medical device concepts:  

• A wearable biosensor for cyanotic congenital heart diseases, a group of congenital heart defects that reduce the amount of oxygen delivered to the body;

• A medical device for non-invasive cardiac assessment in patients with tetralogy of Fallot, a congenital heart defect involving four structural heart abnormalities; 

• A medical device for hip surgery in children with bone fragility;
• A modular rehabilitation tool designed to support upper-limb motor and cognitive exercises in children;
• A device providing dynamic head support for children with severe neuromotor impairments. 

In addition, the project is supporting the preparation of business plans and clinical investigations to assess the feasibility and future market availability of these medical devices. By supporting early-stage innovation, clinical validation and regulatory preparation, OrphaDev4Kids aims to help bring more child-specific medical devices closer to clinical practice.

iKIDS 4RARE 

IKIDS 4RARE is an accelerator programme supporting the creation and development of innovative solutions specifically tailored for children affected by rare diseases, with a focus on three areas: cardiology, rehabilitation and neurology. 

Among its achievements, iKIDS 4RARE has supported the development of a prototype for home rehabilitation in children with spinal muscular atrophy Type 2 and 3. The initiative has also completed an early market access plan focused on brain function monitoring for cardiac surgery patients, and identified three high-priority unmet needs in children with drug-resistant epilepsy. 

DeCODe

DeCODe (Develop Child and Orphan Device Evaluation support) is establishing a platform for the development of safe and effective paediatric orphan medical devices. 

The initiative is supporting the development of four orphan medical devices, including a device to support gait and mobility for children with rare neurological conditions and an expandable collagen plug as a device that allows closing of the fetal membrane after surgery.

Background 

EU4Health is the fourth and largest of the EU health programmes. The EU4Health programme goes beyond an ambitious response to the COVID-19 crisis to address the resilience of European healthcare systems. The programme provides funding to national authorities, health organisations and other bodies through grants and public procurement, contributing to a healthier Europe.  

HaDEA manages the vast majority of the total EU4Health budget and implements the programme by managing calls for proposals and tenders from 2021 to 2027.